July 30, 2016
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Biaxin

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Biaxin, Biaxin XL




Indications
Dosage
How Supplied

INDICATIONS

Acute Bacterial Exacerbation Of Chronic Bronchitis

BIAXIN (Filmtab, Granules) and BIAXIN XL Filmtab are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae [see Limitations of Use].

Acute Maxillary Sinusitis

BIAXIN (Filmtab, Granules) and BIAXIN XL Filmtab (in adults) are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae [see Limitations of Use].

Community-Acquired Pneumonia

BIAXIN (Filmtab, Granules) and BIAXIN XL Filmtab are indicated [see Limitations of Use] for the treatment of mild to moderate infections caused by susceptible isolates due to:

  • Haemophilus influenzae (in adults)
  • Haemophilus parainfluenzae (BIAXIN XL Filmtab in adults)
  • Moraxella catarrhalis (BIAXIN XL Filmtab in adults)
  • Mycoplasma pneumoniae, Streptococcus pneumoniae, Chlamydophila pneumoniae (BIAXIN XL Filmtab [in adults]; BIAXIN Filmtab and BIAXIN Granules [in adults and pediatric patients])

Pharyngitis/Tonsillitis

BIAXIN Filmtab and BIAXIN Granules are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Streptococcus pyogenes as an alternative in individuals who cannot use first line therapy.

Uncomplicated Skin And Skin Structure Infections

BIAXIN Filmtab and BIAXIN Granules are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Staphylococcus aureus, or Streptococcus pyogenes.

Acute Otitis Media

BIAXIN Filmtab and BIAXIN Granules are indicated in pediatric patients for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae [see Clinical Studies].

Treatment And Prophylaxis Of Disseminated Mycobacterial Infections

BIAXIN Filmtab and BIAXIN Granules are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Mycobacterium avium or Mycobacterium intracellulare in patients with advanced HIV infection [see Clinical Studies].

Helicobacter Pylori Infection And Duodenal Ulcer Disease

BIAXIN Filmtab is given in combination with other drugs in adults as described below to eradicate H. pylori. The eradication of H. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence [see Clinical Studies].

  • BIAXIN Filmtab in combination with amoxicillin and PREVACID (lansoprazole) or PRILOSEC (omeprazole) Delayed-Release Capsules, as triple therapy, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or five-year history of duodenal ulcer) to eradicate H. pylori.
  • BIAXIN Filmtab in combination with PRILOSEC (omeprazole) capsules are indicated for the treatment of patients with an active duodenal ulcer associated with H. pylori infection. Regimens which contain BIAXIN Filmtab as the single antibacterial agent are more likely to be associated with the development of clarithromycin resistance among patients who fail therapy. Clarithromycin-containing regimens should not be used in patients with known or suspected clarithromycin resistant isolates because the efficacy of treatment is reduced in this setting.

Limitations Of Use

BIAXIN XL Filmtab is indicated only for acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, and community-acquired pneumonia in adults. The efficacy and safety of BIAXIN XL Filmtab in treating other infections for which BIAXIN Filmtab and BIAXIN Granules are approved have not been established.

There is resistance to macrolides in certain bacterial infections caused by Streptococcus pneumoniae and Staphylococcus aureus. Susceptibility testing should be performed when clinically indicated.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of BIAXIN and other antibacterial drugs, BIAXIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

DOSAGE AND ADMINISTRATION

Important Administration Instructions

BIAXIN Filmtab and BIAXIN Granules may be given with or without food.

BIAXIN XL Filmtab should be taken with food. Swallow BIAXIN XL Filmtab whole; do not chew, break or crush BIAXIN XL Filmtab.

Adult Dosage

The recommended dosages of BIAXIN Filmtab and BIAXIN XL Filmtab for the treatment of mild to moderate infections in adults are listed in Table 1.

Table 1: Adult Dosage Guidelines

Infection BIAXIN Filmtab BIAXIN XL Filmtab
Dosage (every 12 hours) Duration (days) Dosage (every 24 hours) Duration (days)
Acute bacterial exacerbation of chronic bronchitis 250 to 500 mga 7b-14 1 gram 7
Acute maxillary sinusitis 500 mg 14 1 gram 14
Community-acquired pneumonia 250 mgc 7d-14 1 c 1 gram 7
Pharyngitis/Tonsillitis 250 mg 10 - -
Uncomplicated skin and skin structure infections 250 mg 7-14 - -
Treatment and prophylaxis of disseminated Mycobacterium avium disease [see Dosage Regimens for Mycobacterial Infections] 500 mge - - -
H.pylori eradication to reduce the risk of duodenal ulcer recurrence with amoxicillin and omeprazole or lansoprazole [see Combination Dosing Regimens for H. pylori Infection] 500 mg 10-14 - -
H.pylori eradication to reduce the risk of duodenal ulcer recurrence with omeprazole [see Combination Dosing Regimens for H. pylori Infection] 500 mg every 8 hours 14 - -
a For M. catarrhalis and S. pneumoniae use 250 mg. For H. influenzae and H. parainfluenzae, use 500 mg.
b For H parainfluenzae, the duration of therapy is 7 days.
c For H. parainfluenzae and M. catarrhalis use BIAXIN XL tablets only.
d For H. influenzae, the duration of therapy is 7 days.
e BIAXIN therapy should continue if clinical response is observed. BIAXIN can be discontinued when the patient is considered at low risk of disseminated infection.

Combination Dosing Regimens For H. Pylori Infection

  • Triple therapy: BIAXIN Filmtab/lansoprazole/amoxicillin
    The recommended adult dosage is 500 mg BIAXIN Filmtab, 30 mg lansoprazole, and 1 gram amoxicillin, all given every 12 hours for 10 or 14 days [see INDICATIONS AND USAGE and Clinical Studies].
  • Triple therapy: BIAXIN Filmtab/omeprazole/amoxicillin
    The recommended adult dosage is 500 mg BIAXIN Filmtab, 20 mg omeprazole, and 1 gram amoxicillin; all given every 12 hours for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief [see INDICATIONS AND USAGE and Clinical Studies].
  • Dual therapy: BIAXIN Filmtab/omeprazole
    The recommended adult dosage is 500 mg BIAXIN Filmtab given every 8 hours and 40 mg omeprazole given once every morning for 14 days. An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief [see INDICATIONS AND USAGE and Clinical Studies].

Pediatric Dosage

The recommended daily dosage is 15 mg/kg/day divided every 12 hours for 10 days (up to the adult dose). Refer to dosage regimens for mycobacterial infections in pediatric patients for additional dosage information [see Dosage Regimens for Mycobacterial Infections].

Dosage Regimens For Mycobacterial Infections

For the treatment of disseminated infection due to Mycobacterium avium complex (MAC), BIAXIN Filmtab and BIAXIN Granules are recommended as the primary agents. BIAXIN Filmtab and BIAXIN Granules should be used in combination with other antimycobacterial drugs (e.g. ethambutol) that have shown in vitro activity against MAC or clinical benefit in MAC treatment [see Clinical Studies].

Adult Patients

For treatment and prophylaxis of mycobacterial infections in adults, the recommended dose of BIAXIN is 500 mg every 12 hours.

Pediatric Patients

For treatment and prophylaxis of mycobacterial infections in pediatric patients, the recommended dose is 7.5 mg/kg every 12 hours up to 500 mg every 12 hours. [See Use in Specific Populations and Clinical Studies].

BIAXIN therapy should continue if clinical response is observed. BIAXIN can be discontinued when the patient is considered at low risk of disseminated infection.

Dosage Adjustment In Patients With Renal Impairment

See Table 2 for dosage adjustment in patients with moderate or severe renal impairment with or without concomitant atazanavir or ritonavir-containing regimens [see DRUG INTERACTIONS].

Table 2: BIAXIN Dosage Adjustments in Patients with Renal Impairment

  Recommended BIAXIN Dosage Reduction
Patients with severe renal impairment (CLcr of < 30 mL/min) Reduce the dosage of BIAXIN by 50%
Patients with moderate renal impairment (CLcr of 30 to 60 mL/min) taking concomitant atazanavir or ritonavir-containing regimens Reduce the dosage of BIAXIN by 50%
Patients with severe renal impairment (CLcr of < 30 mL/min) taking concomitant atazanavir or ritonavir-containing regimens Reduce the dosage of BIAXIN by 75%

Dosage Adjustment Due To Drug Interactions

Decrease the dose of BIAXIN by 50 % when co-administered with atazanavir [see DRUG INTERACTIONS]. Dosage adjustments for other drugs when co-administered with BIAXIN may be recommended due to drug interactions [see DRUG INTERACTIONS].

Reconstitution Of BIAXIN Granules

The supplied BIAXIN Granules must be reconstituted with water prior to administration of BIAXIN for oral suspension. Table 3 below indicates the volume of water to be added when reconstituting. To reconstitute:

  1. Add half the volume of water to the bottle containing the BIAXIN granules and shake vigorously.
  2. Add the remainder of water to the bottle and shake.

Shake well before each use. After mixing, store at 15° to 30°C (59° to 86°F) and use within 14 days. Do not refrigerate.

Table 3: Volume of Water to be Added When Reconstituting BIAXIN Granules

Total Volume After Reconstitution Clarithromycin Concentration After Reconstitution Amount of Water to be Added
50 mL 125 mg/5 mL 27 mL
100 mL 125 mg/5 mL 55 mL
50 mL 250 mg/5 mL 27 mL
100 mL 250 mg/5 mL 55 mL

HOW SUPPLIED

Dosage Forms And Strengths

BIAXIN is available as:

  • BIAXIN Filmtab (yellow oval film-coated tablet):
    • 250 mg: imprinted in blue with the “a” logo and KT
    • 500 mg: debossed with the “a” logo on one side and KL on the opposite side
  • BIAXIN XL Filmtab (yellow oval film-coated extended-release tablet):
    • 500 mg: debossed with the “a” logo and KJ
  • BIAXIN Granules (white to off-white granules before reconstitution; white to off-white opaque suspension after reconstitution):
    • 125 mg/5 mL concentration available in 50 mL and 100 mL bottles
    • 250 mg/5 mL concentration available in 50 mL and 100 mL bottles

Storage And Handling

BIAXIN Filmtab (clarithromycin tablets, USP) is supplied as yellow oval film-coated tablets in the following packaging sizes:

250 mg tablets: (imprinted in blue with the “a” logo and KT)

Bottles of 60 (NDC 0074-3368-60) and unit dose strip packages of 100 (NDC 0074-3368-11).

Store BIAXIN Filmtab 250 mg at controlled room temperature 15° to 30°C (59° to 86°F) in a well-closed container. Protect from light.

500 mg tablets: (debossed with the “a” logo on one side and KL on the opposite side)

Bottles of 60 (NDC 0074-2586-60) and unit dose strip packages of 100 (NDC 0074-2586-11).

Store BIAXIN Filmtab 500 mg at controlled room temperature 20° to 25°C (68° to 77°F) in a well-closed container.

BIAXIN XL Filmtab (clarithromycin extended-release tablets) is supplied as yellow oval film-coated tablets in the following packaging sizes:

500 mg tablets: (debossed with the “a” logo and KJ)

Bottles of 60 (NDC 0074-3165-60), unit dose strip packages of 100 (NDC 0074-3165-11), and BIAXIN XL PAC carton of 4 blister packages 14 tablets each (NDC 0074-3165-41).

Store BIAXIN XL Filmtab at 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]

BIAXIN Granules (clarithromycin for oral suspension, USP) is supplied as white to off-white granules in the following strengths and sizes:

Total Volume After Constitution Clarithromycin Concentration After Constitution Clarithromycin Contents Per Bottle NDC
50 mL 125 mg/5 mL 1250 mg 0074-3163-50
100 mL 125 mg/5 mL 2500 mg 0074-3163-13
50 mL 250 mg/5 mL 2500 mg 0074-3188-50
100 mL 250 mg/5 mL 5000 mg 0074-3188-13

Store BIAXIN Granules below 25°C (77°F) in a well-closed container. Do not refrigerate the reconstituted BIAXIN granules.

Mfd. by AbbVie LTD, Barceloneta, PR 00617. BIAXIN Granules, 125 mg/5 mL and 250 mg/5 Ml. Mfd. by AbbVie Inc., North Chicago, IL 60064, For AbbVie Inc., North Chicago, IL 60064, U.S.A. Revised: May, 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 6/28/2016

Indications
Dosage
How Supplied

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